MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. TRIVEX SYSTEM RESECTOR HANDPIECE; VARICOSE VEIN ALBATION SYSTEM

Catalog Number	7210387F
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the device for evaluation.The housing and powercord were visually inspected and were found to be acceptable.The handpiece was then connected to a control unit.The drive shaft rotated properly when the run or the window lock button were pressed.We were unable to replicate the reported intermittent failure with this device as it operated properly in all speeds and settings during our evaluation.Upon further inspection, we noted black marker lines on the handpiece's connector end suggesting that the user may have removed the power cord at some point.Upon disassembly, there were no signs of component malfunction or assembly error.There was no injury to the patient as the result of the device nor did this incident resulted in any significant delay in the procedure.Surgeon was able to complete the procedure by changing to a different handpiece.At this time, we could not conclusively determine the root cause of the defect as we were unable to replicate the reported failure.It is possible that there was a high current surge in the handpiece during the procedure.This device is programmed with a safety feature that allows it to stop rotating when a high current flow is detected in the circuit.
Event or Problem Description
Surgeon reported that during the transilluminated phlebectomy (tipp) procedure, the handpiece worked intermittently.He then switched to another handpiece to complete the procedure.There was no injury to the patient as the result of the incident.

• Brand Name: TRIVEX SYSTEM RESECTOR HANDPIECE
• Common Device Name: VARICOSE VEIN ALBATION SYSTEM
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 02148
• MDR Report Key: 8573479
• Report Number: 1220948-2019-00051
• Device Sequence Number: 19420445
• Product Code: DWQ
• UDI-Device Identifier: 00840663106561
• UDI-Public: 00840663106561
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K032387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 7210387F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1